[Boston Scientific/보스톤사이언티픽코리아] Principal QA Specialist

보스톤 사이언티픽 코리아

Posted on 2021.04.15

Location : Seoul, Korea
Career Area : Planning, Management

Job Description


  • The purpose of this role is to provide Quality expertise to support to the local/region/international business objectives as well as provide guidance to employees to facilitate continuous quality improvement.  This QA position is responsible for compliance of products imported/distributed by BSC Korea according to MFDS regulations and BSC quality system.


  • Maintains, advises, and reports on compliance to Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the aforementioned Quality System elements, as applicable to the site.
  • Promotes and develops quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory/compliance oriented initiatives.
  • Monitors, identifies, and reports on key Quality System indicators and takes appropriate action to address areas for improvement.
  • Is responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior.
  • Frequently interacts with and represents the quality function to certain BSC departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas. 
  • Perform KGMP recertification and arrange KGMP audit for manufacturing sites accordingly.
  • Support the regulatory reporting such as adverse event reporting, field action reporting, UDI code registration, etc.
  • Manage 3PL warehouse tasks and support the local labelling and requirements to ensure sustained quality of products distributed by BSC Korea.
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Listed responsibilities are an essential, but not limited to this, of duties associated with the position. Changes to individual responsibility may occur due to business needs.

Job Requirements

  • Minimum 4-8 working experience in Quality for medical device industry.
  • Bachelor’s degree in science (industrial engineering, biomedical engineering, biology, chemistry, other relevant fields) is preferred.
  • Good communication (speaking and writing) skill both in English and Korean
  • Interpersonal and organizational skills
  • Positive attitude and strategic thinking
  • Experience in negotiating with regulatory authorities
  • People management skill

Additional Information

  • 커리어수준 : 중간관리자
  • 급여사항 : 면접 후 협의
  • 고용형태 : 정규직
  • 경력여부 : 경력

Guidelines for Applicants

Company Information

Boston Scientific Korea/보스톤 사이언티픽 코리아

Boston Scientific Korea is an entity of Boston Scientific Corporation (NYSE: BSX), the world’s largest medical device company dedicated to less-invasive therapies. The Company’s products and technologies are designed to reduce risk, trauma, cost, procedure time and the need for aftercare. At Boston Scientific, finding new ways to help patients live better lives is what we do – every one of us, every day. The medical solutions we pioneer enable people to go on living the lives they love. We help clinicians improve patients’ lives by delivering innovative medical technologies that lead the world in quality, reliability and efficacy. We never stop searching for more effective solutions, because we believe we can make life better.

Being formed in December 1996, Boston Scientific Korea is a sales and marketing organization concentrating on delivering the best less invasive therapies to our customers throughout Korea. Our business has grown dramatically over the years and we are committed to maintaining our position as a key player in the industry.

Our aim over the next few years is to continue to build on our strengths and to increase our leadership in the market. As we move forward, we welcome talented candidates to join our organization. We firmly believe that every employee has an important role and that together, we can achieve greater success.


서울 강남구 도곡2동 SEI 타워 19층/Gangnam-gu, Seoul, Korea



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